MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL KNEE PROSTHETIC COMPONENT

Model Number 3C98-3

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Pyramid on the top of the knee has been "chewed off" on two sides and we are unaware as to how.The knee was torqued and locktited as per normal.The knee disconnected from the socket and the patient fell and fractured his clavicle.He is currently in hospital.Email said: he has had a fall and injured himself and we believe that he is at risk if he walks on the current knee.Patient was hanging cloths on the clothesline yesterday (sunday (b)(6) 2022) when he noticed some movement between the knee and socket.The knee then disarticulated from the socket at the female socket adaptor and the patient fell to his right side.He put his right arm out to break his fall and fractured his clavicle on the right side.He was conveyed to hospital by ambulance.He was admitted for observation and pain management.Bed rest and analgesia.On examination two pyramid sides at the top of the pyramid on the knee were damaged.

Event Description

Pyramid on the top of the knee has been "chewed off" on two sides and we are unaware as to how.The knee was torqued and locktited as per normal.The knee disconnected from the socket and the patient fell and fractured his clavicle.He is currently in hospital.Email said: he has had a fall and injured himself and we believe that he is at risk if he walks on the current knee.Patient was hanging cloths on the clothesline yesterday (b)(6) 2022) when he noticed some movement between the knee and socket.The knee then disarticulated from the socket at the female socket adaptor and the patient fell to his right side.He put his right arm out to break his fall and fractured his clavicle on the right side.He was conveyed to hospital by ambulance.He was admitted for observation and pain management.Bed rest and analgesia.On examination two pyramid sides at the top of the pyramid on the knee were damaged.Further information: as previously discussed the female rotatable adaptor/socket that the knee was connected to was an ossur brand.I guess it is possible that given that all components have different fitting "tolerances" that we (bpo) have also contributed to the problem.It would be interesting to get germany's feedback on what sort of external force has contributed to the damage.However we appreciate your offer and gesture to cover the costs and i have no doubt that d., who self-funded the knee will appreciate it also.Going forward we will change the socket adaptor to an otto bock branded one.

• Brand Name: C-LEG
• Type of Device: EXTERNAL KNEE PROSTHETIC COMPONENT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 13257177
• MDR Text Key: 289012179
• Report Number: 9615892-2022-00002
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3
• Device Catalogue Number: 3C98-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male